JP6932707B2 - A cartridge for chemical injection having a flexible bag, and a method for manufacturing the cartridge. - Google Patents

Description

The present invention relates to the technical field of a syringe for injecting a drug.

Currently, sterile powder raw materials are predominantly packed in aluminum containers or plastic bags (usually made of polyethylene) by the manufacturer of the active material.

What has been demonstrated by manufacturers to sell these is that all raw materials are stable for a given period of time in the container or in the bag used, as well as maintaining sterilization. Such powders will not deteriorate for a certain number of years if stored in such containers or bags.

The sterile raw materials are sold to the final pharmaceutical manufacturer, where the final product in the form of sterile powder, packaged by conventional techniques and contained in bottles, is shipped to the market. The bottle comes with a glass vial containing the solvent.

The use of good quality materials (glass) for vials, compatible materials for sterile powders, and disposable syringes makes these systems very expensive overall.

The use of syringes provided with space for accommodating cartridges made of flexible materials containing pharmaceutical substances that are isolated until use by a suitable breakable wall is known in the art. An example of such a known device is disclosed in Patent Document 1.

U.S. Patent Application Publication No. 2001/0047162

However, such prior art devices have some drawbacks. In fact, not all doses are released because the mixture or pharmaceutical substance accumulates and stays in the corners of the cartridge. This results in inaccurate dosing of the substance that is actually injected and is not very reliable.

An object of the present invention is to solve problems of the prior art while considering the requirements in this field.

Specifically, an object of the present invention is to provide a system that releases a pharmaceutical substance at a high precision dose by a simple and inexpensive system.

Such an object is achieved by the method of manufacturing the cartridge according to claim 1, the syringe for the cartridge according to claim 14, the injection kit according to claim 19, and the cartridge according to claim 20. ..

The features and advantages of the cartridges, syringes, and methods according to the invention will become clear from the following description according to the accompanying drawings as non-limiting examples.

FIG. 1A is an unequal angle projection of a cartridge according to an embodiment of the present invention. FIG. 1B is a side view of a cartridge according to an embodiment of the present invention. FIG. 2A is an unequal angle projection of the syringe for the cartridge of FIG. FIG. 2B is a side view of the syringe for the cartridge of FIG. FIG. 3 is a diagram of a system formed by accommodating a cartridge in a syringe. FIG. 4 is a diagram of a syringe-cartridge system with an intermediate usage configuration. FIG. 5 is a diagram of a syringe-cartridge system in the final usage configuration. FIG. 6 is a schematic view of a machine for manufacturing a cartridge according to the present invention. FIG. 7 is a diagram showing a stage of manufacturing a cartridge according to the present invention. FIG. 8 is a diagram showing a stage of manufacturing a cartridge according to the present invention. FIG. 9 is a diagram showing a stage of manufacturing a cartridge according to the present invention. FIG. 10 is a diagram showing a stage of manufacturing a cartridge according to the present invention. FIG. 11 is a diagram of an additional embodiment of the cartridge according to the present invention. FIG. 12 is a diagram of an additional embodiment of the cartridge according to the present invention.

According to the attached figure, the cartridge 10 includes at least chambers 12 and 14 containing at least the pharmaceutical substances S, P and L.

According to the modified embodiments of FIGS. 11 and 12, the cartridge 10 includes a single chamber 12 containing the injection solution S.

According to the modified embodiment of FIG. 1, the cartridge 10 includes a first chamber 12 or anterior chamber and a second chamber 14 or a rear chamber, which are separated by a breakable bulkhead 16.

As shown in FIG. 1, each of the chambers 12 and 14 contains one of the components of the injection solution S, for example, the first chamber 12 contains the sterile drug powder P and the second. The chamber contains liquid L, the latter typically a solvent or additional pharmaceutically active ingredient. For example, the sterilized drug powder P is a crystalline powder or a powder obtained by freeze-drying a solution and then collectively obtaining the powder.

The cartridge 10 is composed of a thin film wall. The monolayer or multilayer film is usually made of a plastic material, preferably polyethylene. In the case of a multilayer film, the polyethylene layer is an inner layer that is a layer that comes into contact with a pharmaceutical product.

The cartridge 10 includes at least the small bags 18 and 22 that surround the chambers 12 and 14, and the small bags 18 and 22 face the first side walls 18a and 22a formed of the membrane and the first side wall. It is composed of second side walls 18b and 22b on opposite sides.

According to the modification of FIG. 1, the cartridge 10 includes a first small bag 18 or a front small bag surrounding the first chamber 12, and the first small bag 18 is a first side wall formed of a membrane. It is composed of 18a and a second side wall 18b facing the first side wall 18a and opposite to the first side wall 18a.

Preferably, the first wall 18a is joined to the second side wall 18b via a joint end, eg, along the side ends 20', 20', and along the front end 20'''. For example, they are welded or bonded. Instead, an additional side wall or membrane lower wall is provided between the first wall and the second wall and is appropriately joined to the side wall via a welded or bonded end.

Similarly, the cartridge 10 includes a second small bag 22 or a rear small bag that surrounds the second chamber 14, and the second small bag 22 has a first side wall 22a formed of a membrane and a first side wall 22a. It is composed of a second side wall 22b facing the side wall 22a of 1 and on the opposite side.

Preferably, the first wall 22a is joined to the second side wall 22b via a joint end, eg, along the side ends 22', 22', and to the rear end 22'''. Along, for example, welded or glued. Alternatively, an additional side wall or membrane lower wall is provided between the first wall and the second wall and is appropriately joined to the side wall via a welded or bonded end.

Preferably, the cartridge 10 includes an injection needle 30, which is attached to a small bag, eg, so as to project from the front end 20 ″. Preferably, the needle 30 is connected to the small bag by the needle-carrying component 32.

According to the modified form of FIG. 1, the breakable partition wall 16 is arranged between the first chamber 12 and the second chamber 14. For example, the partition wall is obtained by additional welding between the side walls 18a, 18b of the first chamber 12, or the side walls 22a, 22b of the second chamber, and is realized to separate the chamber 12 and the chamber 14. NS. Alternatively, the partition wall is realized by an additional membrane wall appropriately joined to the side wall of the small bags 18 and 22.

Preferably, the cartridge 10 has a bottom 35 on the opposite side of the needle 30 that comes into contact with the head 113 of the plunger 110, which will be described later.

Preferably, when the cartridge 10 is in the undeformed state, the bottom 35 has an outwardly curved portion 35a, which is typically concave outwards, to squeeze a small bag and to be completely empty. Will be easier to do.

Preferably, the curved portion 35a is asymmetric and is formed by a bottom portion 35 that narrows toward one side of the small bag and collapses at the rear end 22 ″. Such a "whistle" structure of the bottom 35 facilitates sliding of the plunger 110.

Preferably, the cartridge 10 has a head surface 37 that is convex outward, from which the needle 30 projects. For example, the head surface 37 has a dome shape. Such a dome-shaped structure of the head 37 makes it easy to empty the small bag. In fact, since there are no corners or recesses, no accumulation or retention of the mixture or pharmaceutical substance remains in the small bag and the small bag is completely emptied.

Preferably, the head surface 37 is asymmetric with respect to the spindle X and narrows starting from one side of the small bag. Such a structure allows preferential squeezing of one side of the cartridge, making it easier to empty the small bag.

Preferably, the shape of the head surface 37 is complementary to the shape of the head 113 of the plunger 110 and the shape of the bottom 122 of the distal end 106 of the syringe 100. Such a structure allows for complete squeezing of the cartridge.

The cartridge 10 is also provided with engaging means that mechanically engage the cartridge with the syringe 100 (discussed in detail later).

Preferably, the engaging means is a plurality of engaging elements projecting from the small bag 40. Including i.

For example, the cartridge 10 has a pair of upper engaging elements 40.1. 40.2 is provided.

Preferably, the cartridge 10 also has a pair of lower engaging elements 40 of the engaging means that project from a second small bag, eg, from each of the side walls 22b, 22a, or from the rear end 22'''. .3, 40.4 are provided.

Preferably, the cartridge 10 is also provided with a pair of intermediate engaging elements 40.5, 40.6 of the engaging means that project corresponding to the bulkhead 16 separating the two chambers 12, 14. Has been done.

The present invention also provides a syringe 100 of a cartridge 10 according to the embodiment shown in FIG.

The syringe 100 includes, for example, a tubular, typically cylindrical body 102, the body 102 having a proximal end 103 with a proximal opening 104, primarily along the main axis X direction, and a tubular body 102. The base 108 of the is located, eg, attached, extends between the opposite distal end 106.

The syringe 100 also includes a plunger 110 that carries the head 113, and by pushing the plunger, the head 113 is inserted into the tubular body through the proximal opening 104 and slid within the tubular body 102. Can be done.

The tubular body 100 has an internal storage space 120 that is available by opening the movable wall 130 of the tubular body 102 and is designed to accommodate the cartridge 10 in the original configuration of the syringe 100.

The syringe 100 is provided with engaged means that are mechanically engaged with the engaging means of the cartridge to fix the mutual arrangement of the cartridge 10 and the syringe 100.

For example, the engaged means has a plurality of through holes 140. The engaging element 40 of the cartridge 10, including i. i is the hole 140. It is inserted into i and fixed to them.

For example, the engaged means is the engaging element 40. To secure i to the syringe, typically hole 140. Engagement element inserted into i 40. Includes a holding wall that is adapted to engage i. For example, there is usually a sliding or rotating wall or embedded wall that can close the through hole, thus the hole 140. Engagement element by closing i 40. i is retained.

According to an alternative embodiment, a fixed snap fitting element is provided on the outer wall of the cartridge and the engaging element of the cartridge 40. It is designed to cooperate with the other party's fixed element provided in i.

For example, the syringe 100 is provided with a pair of upper engaging holes 140.1, 140.2 of the engaged means, which are tubular through the base 108 or in a region near the base 108. It is arranged so as to penetrate the main body 102 so as to engage with the upper engaging elements 40.1 and 40.2 of the first small bag 18.

Preferably, the syringe 100 is further provided with a pair of lower engaging holes 140.3, 140.4 of the engaged means, which are arranged near the proximal end 103 of the tubular body 102. It is adapted to engage the lower engaging elements 40.3 and 40.4 of the second small bag 22.

For example, at least one of the lower through holes 140.3 and 140.4 is arranged in the movable wall 130.

Typically, the syringe 100 is further provided with a pair of intermediate engaging holes 140.5, 140.6 of the engaged means, which are upper holes 140.1, 140.2 and lower holes. It is arranged between 140.3 and 140.4 so as to penetrate the axial intermediate region of the tubular body 102, and the intermediate holes 140.5 and 140.6 are the intermediate engaging elements 40.5 of the cartridge 10. It is designed to engage with 40.6.

The base 108 is also provided with a small window 111 for inserting the needle 30, which penetrates the axial depth.

Alternatively, the base 108 is also provided with a radial channel 112 extending from the periphery of the base 108 to the center through the thickness of the base and ending with a small window 110.

The channel 112 is open at a corner position on the periphery of the base 108 that is included in the corner extension of the movable wall 130 so that the needle 130 moves radially through the channel 112 to reach the window 110. In between, the small bags 18 and 22 can be accommodated in the space 120.

Preferably, the needle-supporting component 32 can be further fixed in the small window 110 by shape fitting or by interfering with it.

According to a preferred embodiment, the head 113 of the plunger 110 is dome-shaped, convex towards the space 120 and preferably asymmetric with respect to the main axis X, so that one side of the cartridge 10 is preferentially squeezed.

Preferably, further, the syringe 100 has a bottom 122 at the distal end 106 corresponding to the base 108, which is concave towards space 120 and is opposite to the head 113. , Complementary to the head 113, facilitating squeezing of the cartridge 10.

In the normal operation of the system according to the invention, the syringe 100 is initially in the initial configuration, where the plunger 110 is in the retracted position, so that a storage space 120 is defined within the tubular body 102 to house the cartridge 10. To be done.

In such a syringe 100 configuration, when the movable wall 130 is open, the cartridge 10 is inserted into the accommodation space 120 and the needle 130 preferentially moves through the channel 112 and is provided through the small window 110. The cartridge is fixed to the syringe by engaging the cartridge engaging means and the syringe engaged means.

Specifically, each engaging element 40. i is the respective engaging holes 140. Fix the cartridge to the syringe by inserting it into i.

When the movable wall 130 is closed, the system is ready for use.

When the plunger 110 is moved, the head 113 becomes a small bag held at the bottom by engaging the lower engaging elements 40.3 and 40.4 with the lower engaging holes 140.3 and 140.4, respectively. It is pressed.

The concave bottom 35 of the small bag works with the dome-shaped head 113 of the plunger 110 to ensure that the chamber is completely emptied.

The plunger can be advanced to a forward position where the head is near the bottom 122 and the cartridge is completely squeezed between the head 113 and the bottom 122 (FIG. 5).

The plunger head 113 completely squeezes the dome-shaped head surface 37 of the small bag to ensure complete release of the solution.

Once the injection is complete, the syringe can be opened and the empty cartridge removed and placed in a separate, eg, waste disposal. On the other hand, the syringe can be reused preferentially.

According to the modified embodiment of FIG. 1, the pressure in the second chamber 14 increases due to the squeezing of the second small bag 22, and the partition wall 16 is broken (FIG. 4).

Thus, the liquid L flows into the first chamber 18 containing the powder P, resulting in the formation of a mixture to be injected.

The concave bottom 35 of the small bag 22 cooperates with the dome-shaped head 113 of the plunger 110 to ensure that the liquid L is completely discharged.

When the plunger 110 is pushed further, the first small bag 18 is squeezed and the injected solution S flows out through the needle 30, during which time the second small bag 18 has an upper engagement hole 140.1. It is firmly anchored to the syringe by the upper engaging elements 40.1 and 40.2 inserted and secured in 140.2.

The head 113 of the plunger 110 completely squeezes the dome-shaped head surface 37 of the first small bag 18 to ensure that the solution is completely discharged.

Manufacture of the cartridge according to the invention follows the steps of a mechanized and fixed method, which will be described in detail below.

A machine provided with a sterilization chamber 200 prepares the first continuous membrane piece 202 and the second continuous membrane piece 204 so as to face each other.

For example, the machine is provided with rolls 205 from which the membranes 202, 204 are pulled out.

The machine is also provided with a supply device 210 that includes at least two tubes 212, 214, each of which provides a predetermined amount of mixture components under control, such as a predetermined amount of powder P and a predetermined amount of liquid L. It is designed to supply.

The machine is also provided with a joining device 220 for joining two films and forming a joining end between them.

For example, the joining device 220 includes a welding device that includes welding heads 222 and 224 that are placed face-to-face and through which membranes 202 and 204 pass.

In the first manufacturing stage, the front end portion 20''' of the cartridge 10 is realized, for example, the welding front end portion 20''' is realized by bringing the welding heads 222 and 224 close to each other and fastening the two films 202 and 204 together. '' (And optionally the side edges 20', 20'' of the small bag) are formed to form a chamber with an opening side.

Next, a feeding step of the solution to be injected (in the case of the modified embodiments of FIGS. 11 and 12) or a feeding step of the first component of the solution (in the case of the modified embodiment of FIG. 1). For example, the powder P supply stage is performed.

Therefore, in the case of the modified embodiment of FIG. 1, the first pipe 212 is moved to the forward position in some cases to discharge a predetermined amount of powder P (FIG. 7).

Next, the membranes 202, 204 are fed in the forward direction, and then the bonding device is restarted to perform the step of forming the breakable partition wall 16.

For example, the welding heads 222 and 224 are brought close to each other to realize the welding portions of the films 202 and 204 forming the partition wall 16 (FIG. 8).

Next, the membranes 202 and 204 are fed in the forward direction, and then a supply step of the second component of the solution, for example, a supply step of the liquid L is performed.

For this purpose, in some cases, the second pipe 214 is moved to the forward position to discharge a predetermined amount of liquid L (FIG. 9).

Finally, in both the modified form of FIG. 1 and the modified form of FIG. 11, the second pipe 214 or both pipes 212 and 214 may be retracted, and then, for example, the welding heads 222 and 224 are brought closer to each other after the small bag. The end 22'''is formed (Fig. 10).

According to one embodiment, the engaging element of the cartridge 40. i is integrated with the film realized by the cartridge, for example, in the form of a tape which is appropriately cut and the unnecessary portion is appropriately removed.

Alternatively, the engaging element 40. i is realized separately from the small bags 18 and 22 of the cartridge, and is later attached to the small bag by, for example, adhesion.

The concave asymmetric bottom 35 and head surface 37 are realized, for example, by thermoforming or blow molding.

Another object of the present invention is an injection kit comprising a syringe and a cartridge 10. In one modified embodiment, the injection kit comprises one syringe 100 and a plurality of cartridges 10.

Innovatively, the cartridges and syringes according to the invention overcome the disadvantages of the prior art in that the solution to be injected is completely injected without changing the dose.

Advantageously, the outer shape of the cartridge, basically the inwardly concave head, and the outer shape of the syringe, basically the dome-shaped head of the plunger, allow the cartridge to be completely emptied. And the accuracy of the dose is also guaranteed. In fact, no buildup or retention of mixture or pharmaceutical substance remains in the small bag and the small bag is completely emptied.

Advantageously, the outer shape of the cartridge, essentially the rear portion provided with the asymmetrical bend, helps facilitate the sliding of the plunger and facilitates the release of the injectable material.

Advantageously, the cartridges, syringes, and methods according to the invention can also significantly reduce the cost of manufacturing an injection system for pharmaceutical mixtures. In fact, since the cartridge is mounted by a piece of thin film, there is no need for a glass vial to hold the liquid or mixture components.

Advantageously, the cost of the system is further reduced because the production volume can be significantly increased by routine production.

Advantageously, the system also allows the syringe to be reused, resulting in lower cost for the end user.

According to another advantageous embodiment, the use of a system with a double chamber cartridge according to the invention is particularly safe, especially for patients, as it eliminates the possibility of erroneous dosing and mixing of the components of the mixture.

Moreover, the use of this system is particularly simple and safe as the cartridge is held firmly in place with respect to the syringe.

It will be apparent that those skilled in the art may make modifications to the cartridges, syringes, and methods described above to meet the accompanying requirements, all of which are within the scope of the claims set forth below.

Claims (18)

A cartridge (10) for injecting a drug when contained in a syringe.
It is composed of a thin film wall,
Extending in the main axis (X) direction,
Containing at least one small flexible bag (18, 22) surrounding the chamber (12, 14) containing the pharmaceutical substance (S, P, L).
It has a dome-shaped head surface (37) that is convex outward, and has a dome-shaped head surface (37).
The head surface (37) is asymmetric with respect to the main axis (X) and is narrowed starting from one side of the small bag.
Cartridge for chemical injection (10). The cartridge according to claim 1, which has a bottom portion (35) having a curved portion (35a) that is concave outward. The cartridge according to claim 2 , wherein the curved portion (35a) is asymmetric and is formed by the bottom portion (35) narrowing toward one side of the small bag (22). The cartridge according to any one of claims 1 to 3 , wherein at least one of the bottom portion (35) and the head surface (37) is realized by thermoforming or blow molding. The small bag (18, 22) is composed of a first side wall (18a, 22a) formed of a membrane and a second side wall (18b, 22b) facing the first side wall and opposite to the first side wall. The cartridge according to any one of claims 1 to 4, which is configured. The cartridge according to any one of claims 1 to 5 , wherein the membrane is a polyethylene single-layer membrane or an inner layer is a polyethylene multilayer membrane. Needle bearing mounted on said first small bag composed of elements (32), comprising said needle (30) projecting from the head surface (37), according to any one of claims 1 to 6 cartridge. The engaging means includes an engaging means (40.i) for mechanically engaging the cartridge (10) with the syringe (100) and holding it in place, the engaging means being the first small bag (18). ), The cartridge according to any one of claims 1 to 7 , which protrudes from at least one of the second small bag (22) and the partition wall (16) region. A first chamber (12) containing a first component (P) of a solution and a second chamber (14) containing a second component (L) of a solution, respectively. Claims 1-8 , comprising a small bag (18) and a second small bag (22), wherein the chamber is separated by a breakable partition (16) so that the components are mixed. The cartridge (10) according to any one item. The first small bag (18) includes side walls (18a, 18b) made of a thin film and is joined along a joining end to define the first chamber (12). The small bag (22) includes side walls (22a, 22b) made of a thin film and is joined along the joint end to define the second chamber (14), the partition wall (16). The cartridge according to claim 9 , further comprising a joint end portion common to the first small bag (18) and the second small bag (22). The cartridge (10) according to any one of claims 1 to 8 , comprising a single chamber (12) containing the injection solution (S). A main body (102) extending along the main axis (X) direction and provided with a storage space (120) for storing the cartridge (10).
A plunger (110) having a dome shape, convex toward the space (120), and provided with a head (113) asymmetric with respect to the main axis (X).
A fixed bottom portion (122) provided on the main body (102) and concave toward the space (120).
Including
The fixed bottom (122) is on the opposite side of the plunger's head (113) and has a concave shape complementary to the convex shape of the head (113).
Syringe (100) . It said body (102) is cylindrical, including a movable wall (130) which can be opened to allow use of the receiving space (120), the syringe (100) according to請Motomeko 12. The engaged means for mechanically engaging with the cartridge (10) and holding the cartridge (10) in a predetermined position is included, and the engaging element (40.i) of the cartridge (10) penetrates the engaged means. The syringe (100) according to claim 12 or 13 , comprising a plurality of engaging holes (140.i) suitable for use. The engagement holes (140.1, 140.2) are provided so as to penetrate the base portion (108) from which the needle (30) protrudes from the cartridge (10), or the plunger (110) is inserted. The syringe (100) according to claim 14 , which is at least one provided in the vicinity of the proximal opening (104). An injection kit for injecting a drug solution, comprising the syringe (100) according to any one of claims 12 to 15 and at least one cartridge (10) according to any one of claims 1 to 11. A method for manufacturing a cartridge (10) for injection of a chemical solution (S).
A step of arranging and preparing the first continuous film piece (202) and the second continuous film piece (204) so as to face each other,
A step of realizing a chamber (12) in which the upper part of the cartridge (10) is open by joining the two films (202, 204) along the joining end portion.
A step of supplying a predetermined amount of a pharmaceutical substance (S, P, L) to the opening chamber (12), and
The step of closing the chamber (12) by the rear end,
A step of realizing a convex head surface (37) that becomes a dome shape outward by thermoforming or blow molding, and
A step to achieve a concave asymmetric bottom (35) by thermoforming or blow molding,
How to include. The step of supplying the pharmaceutical substance (S, P, L) comprises supplying a predetermined amount of the first component (P) of the solution (S) to the first opening chamber (12).
The step of closing the chamber is
A second chamber (14) of the cartridge (10) with an open top is realized by joining the two membranes (202, 204) along a further joint end. Consists of one of the additional junction ends, which closes the top of the first chamber (12) and separates the first chamber (12) from the second chamber (14). What can be achieved by forming a breakable partition wall (16)
Supplying a predetermined amount of the second component (L) of the solution (S) to the second opening chamber (14),
Closing the second chamber (14) by the rear end (22''') and
17. The method of claim 17.

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